Intra-Cellular Therapies to Present at the CNS Summit 2015 Conference
October 09 2015 - 8:00AM
Intra-Cellular Therapies, Inc. (Nasdaq:ITCI) a biopharmaceutical
company focused on the development of therapeutics for central
nervous system (CNS) disorders, announced today that top-line data
from the Phase 3 ITI-007-301 clinical trial will be presented at
the CNS Summit 'Shaping the future of Drug Development' 2015
Conference being held in Boca Raton, Florida October 8-11, 2015. A
poster presentation of the data is scheduled for Friday, October 9,
2015 and an oral presentation by Kimberly Vanover, Ph.D., Vice
President of Clinical Development is scheduled for Sunday, October
11, 2015. The presentations will feature the previously
announced top-line data from ITI-007-301, the Company's first Phase
3 clinical trial in patients with schizophrenia.
As previously announced, ITI-007-301 is the first Phase 3
clinical trial of ITI-007 for the treatment of patients with
schizophrenia. In this trial, once-daily ITI-007 60 mg met the
primary endpoint and demonstrated antipsychotic efficacy with
statistically significant superiority over placebo at Week 4 (study
endpoint) as measured by the change from baseline on the Positive
and Negative Syndrome Scale (PANSS) total score (p=0.022).
Moreover, ITI-007 60 mg showed significant antipsychotic efficacy
as early as week 1, which was maintained at every time point
throughout the entire study. ITI-007 60 mg also met the key
secondary endpoint of statistically significant improvement on the
Clinical Global Impression Scale for Severity of Illness (CGI-S;
p=0.003). These findings confirm the positive results demonstrated
by ITI-007 60 mg in the Company's Phase 2 study. Consistent with
previous studies, ITI-007 had a favorable safety and tolerability
profile as evidenced by motoric, metabolic, and cardiovascular
characteristics similar to placebo, and no clinically significant
changes in akathisia, extrapyramidal symptoms, prolactin, body
weight, glucose, insulin, or lipids.
About Intra-Cellular Therapies
Intra-Cellular Therapies is developing novel drugs for the
treatment of neuropsychiatric and neurodegenerative diseases and
diseases of the elderly, including Parkinson's and Alzheimer's
disease. The Company is developing its lead drug candidate,
ITI-007, for the treatment of schizophrenia, bipolar disorder,
behavioral disturbances in dementia, depression, and other
neuropsychiatric and neurological disorders. ITI-007, a
first-in-class molecule, is in Phase 3 clinical development for the
treatment of schizophrenia. The Company is also utilizing its
phosphodiesterase platform and other proprietary chemistry
platforms to develop drugs for the treatment of Central Nervous
System (CNS) disorders and other disorders.
Forward-Looking Statements
This news release contains "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of 1995
that involve risks and uncertainties that could cause actual
results to be materially different from historical results or from
any future results expressed or implied by such forward-looking
statements. Such forward-looking statements include statements
regarding, among other things, our clinical and nonclinical
development plans; the progress, timing and results of our clinical
trials; the safety and efficacy of our product development
candidates; our beliefs about the potential uses and benefits of
ITI-007; our plans to present or report additional data; and our
research and development efforts and plans under the caption "About
Intra-Cellular Therapies." All such forward-looking statements are
based on management's present expectations and are subject to
certain factors, risks and uncertainties that may cause actual
results, outcome of events, timing and performance to differ
materially from those expressed or implied by such statements.
These risks and uncertainties include but are not limited to the
following: our current and planned clinical trials, other studies
for ITI-007, and our other product candidates may not be successful
or may take longer and be more costly than anticipated; product
candidates that appeared promising in earlier research and clinical
trials may not demonstrate safety and/or efficacy in larger-scale
or later clinical trials; our reliance on collaborative partners
and other third parties for development of our product candidates;
and the other risk factors discussed under the heading "Risk
Factors" contained in our Annual Report on Form 10-K for the year
ended December 31, 2014 filed with the Securities and Exchange
Commission (SEC), as well as any updates to those risk factors
filed from time to time in our periodic and current reports filed
with the SEC. All statements contained in this press release are
made only as of the date of this press release, and we do not
intend to update this information unless required by law.
CONTACT: Intra-Cellular Therapies, Inc.
Juan Sanchez, M.D.
Vice President,
Corporate Communications and Investor Relations
212-923-3344
Burns McClellan, Inc.
Lisa Burns (Investors)
Justin Jackson (Media)
jjackson@burnsmc.com
212-213-0006
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